Registration Dossier

Administrative data

Description of key information

An acute oral study was carried on Wistar rats to determine the acute oral toxicity of Basic Red 76. Groups of 3 male and 3 female rats received a single oral dose of 2000 mg/kg bw.
The LD50 was reported to be greater than 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
not specified
Test type:
other: No data
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
No data
Route of administration:
oral: gavage
Vehicle:
propylene glycol
Details on oral exposure:
VEHICLEConcentration in vehicle: Basic Red 76 in propylene glycolLot/batch no. (if required): 00506441 01 (of the target)MAXIMUM DOSE VOLUME APPLIED: 2000mg/kgbw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Groups of 3 male and 3 female rats
Control animals:
not specified
Details on study design:
Duration of observation period following administration: 14 days (or other?): 15 daysFrequency of observations and weighing: DailyNecropsy of survivors performed: yes/no: yes Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15).
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred
Clinical signs:
Hunched posture was noted in one female and 3 males on day 1. Red staining of the back and/or snout and/or head was noted in 1 female and 2 males between days 1 and 11.
Body weight:
The mean body weight gain over the study period was considered to be normal.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.
Other findings:
Red and/or yellow faeces and/or yellow urine were seen among the animals on days 2 and/or 3.
Interpretation of results:
not classified
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
An acute oral study was carried on Wistar rats to determine the acute oral toxicity of Basic Red 76. Groups of 3 male and 3 female rats received a single oral dose of 2000 mg/kg bw.The LD50 was reported to be greater than 2000 mg/kg bw.
Executive summary:

An acute oral study was carried on Wistar rats to determine the acute oral toxicity of Basic Red 76.

Basic Red 76 was administered by oral gavage to a group of three female Wistar rats and subsequently to a group of three male Wistar rats at 2000 mg/kg bw. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15).

No mortality occurred. Hunched posture was noted in one female and 3 males on day 1. Red staining of the back and/or snout and/or head was noted in 1 female and 2 males between days 1 and 11. Red and/or yellow faeces and/or yellow urine were seen among the animals on days 2 and/or 3. The mean body weight gain over the study period was considered to be normal. No abnormalities were found at macroscopic post mortem examination of the animals.

 

The LD50 was reported to be greater than 2000 mg/kg bw
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Data is of K4 level obtained from Scientific Committee on Consumer Safety SCCS - OPINION ON Basic Red 76

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute toxicity: Oral

In the Scientific Committee on Consumer Safety SCCS - OPINION ON Basic Red 76 (2011), An acute oral study was carried on Wistar rats to determine the acute oral toxicity of Basic Red 76. Groups of 3 male and 3 female rats received a single oral dose of 2000 mg/kg bw. The LD50 was reported to be greater than 2000 mg/kg bw.

In another study, an acute oral study was carried on CFY rats to determine the acute oral toxicity of Basic Red 76. Groups of 2 male and 2 female rats received oral dose of 0, 100, 1000, 4000, 8000, 16000 mg/kg in a volume of 1 to 40 ml/kg through gavage. The LD50 was reported to be greater than 16000 mg/kg bw.

Similarly, an acute oral study was carried on CF1 mice to determine the acute oral toxicity of Basic Red 76. Groups of 3 male mice received a single oral dose of Basic Red 76 at dose levels of 1000, 2510 and 5010 mg/kg bw, 10 male mice received the top dose of 10000 mg/kg bw. The LD50 was reported to be greater than 10000 mg/kg bw.

For a similar substance (CAS: 68391-32-2), acute oral toxicity studies are reported in SCIENTIFIC COMMITTEE ON CONSUMER PRODUCTS SCCP Opinion on Basic Brown 17 (2003)

CFY rats (male/female) were exposed orally to test chemical (8-((4-Amino-3-nitrophenyl)azo)-7-hydroxy-2-naphthyl)trimethylammonium chloride.

Based on the mortality of 2 male rats and 1 female rat from the highest dose group , the LD50 value was determined to be between 8000 and 16000 mg/kg bw, respectively.

Similarly, CF1 male mouse were exposed orally to test chemical(8-((4-Amino-3-nitrophenyl)azo)-7-hydroxy-2-naphthyl)trimethylammonium chloride.

The LD50value was determined to be greater than5000 mg/kg bw.

For a similar substance (CAS: 26381-41-9), acute oral toxicity studies are reported in Scientific Committee on Consumer Safety SCCS - OPINION ON Basic Brown 16 COLIPA nĀ° C9 (2012)

CFY rats (male/female) were exposed orally to test chemical [8-[(p-aminophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride.

The LD50 was reported to be between 2000 and 4000 mg/kg bw.

Similarly, CF1 male mouse were exposed orally to test chemical [8-[(p-aminophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride.

LD50 was considered to be 7800 mg/kg bw when CF1male mice were treated with Basic Brown 16.

Overall reported acute toxicity studies of Basic Red 76 and its read-across substance, indicate that the substance is not likely to exhibit acute oral toxicity can be classified as 'non-hazardous' as per the CLP classification criteria. 


Justification for selection of acute toxicity ā€“ oral endpoint
An acute oral study was carried on Wistar rats to determine the acute oral toxicity of Basic Red 76. Groups of 3 male and 3 female rats received a single oral dose of 2000 mg/kg bw.
The LD50 was reported to be greater than 2000 mg/kg bw.

Justification for classification or non-classification

On the basis of available data, the substance Basic red 76 is not likely to exhibit acute toxicity can be classified as 'non-hazardous' as per the CLP classification criteria.